DairyFoods April 2012 : Page-54

FOOD SAFETY Time to get ready for FSMA The Food Safety Modernization Act became law in 2011. The FDA is now writing proposed regulations that will likely take effect next year. What do dairy companies need to do to get ready? Ⅲ Joseph A. Levitt, By Joseph A. Levitt partner, Hogan Lovells US LLP, Washington, D.C. T he most sweeping set of food safety reforms of our lifetime was signed into law by President Obama in January 2011. Called the FDA Food Safety Modernization Act (FSMA), the Food and Drug Administration is now writing pro-posed regulations that will likely take effect next year. What do dairy companies need to do to get ready? Here are four critical areas for you to focus on now. It’s all about prevention The guiding principle behind FSMA is that the food safety system— as instituted by the food industry and overseen by the FDA—should be based on prevention. Enactment of the law followed a series of foodborne illness outbreaks, and Congress decided it would be better to prevent food safety problems from occurring, rather than reacting to outbreaks and recalls after the fact. To achieve this goal, FSMA requires each dairy facility to have a food safety plan. Based on well-known HACCP (Hazard Analysis and Critical Control Points) principles, each dairy company will soon be required to conduct a detailed analysis of the reasonably foreseeable hazards present in each facility and then design and implement pre-ventive controls to significantly minimize those hazards. Many food companies have implemented HACCP in their facilities for years, and those companies should simply review their HACCP plans and tweak them as needed to meet the new law’s requirements. This means making sure the plan addresses all the potential hazards listed in the law, as well as ensuring there is scientific validation that each set of controls is indeed effective. These steps can all be undertaken now. Other steps will need to await FDA’s regulations; particularly the scope and extent of testing FDA will want to see. FSMA envi-sions a robust set of verification activities to be sure the controls in the food safety plan are effective. These activities are to include product and environmental testing, but the jury is still out on the scope and extent needed. Oversight of suppliers will be in the spotlight The prevention theme extends not just to a dairy company’s own facilities, but to its ingredient suppliers as well. Congress recog-nized the fact that a single contaminated ingredient could cause the recall of literally hundreds, or in some cases, even thousands of finished products. Congress also recognized the fact that there were simply too many ingredient suppliers for the FDA to monitor all by itself, so the law places responsibility on the finished product manufacturer to do so. Supplier verification applies to both domestic and foreign sup-pliers, and FDA is expected to apply comparable requirements to both. FSMA gives dairy companies some latitude to decide how, and how extensively, to oversee their suppliers. For example, dairy companies might choose to conduct an on-site inspection of the supplier, to test incoming ingredients, and/or to review the sup-plier’s HACCP plans. The key is that the manufacturer’s oversight needs to be sufficient to ensure the supplier is meeting the same food safety requirements as the manufacturer. It is expected that FDA will provide for some role, particularly for foreign suppliers, for third party certification programs, such as those benchmarked under the Global Food Safety Initiative 54 Dairy Foods | April 2012